The functions of this core will include biostatistical coordination and oversight of data collection and analysis. It will: 1) provide consultation regarding the designs, and analyses for the projects proposed in this grant, 2) collaborate with clinical investigators on the statistical and scientific aspects of planned protocols, including review and approval of protocols by the biostatistician before resubmission to the IRB and subsequent activation, 3) provide statistical support to the non-clinical investigators on an ongoing basis, 4) assist with preparation of analyses for publication and presentation, 5) provide quality controlled data management for the projects in this application, 6) collect and enter data generated by the clinical studies, 7) design forms for clinical studies, 8) develop and maintain the database for clinical protocols, 9) assist with quality control procedures, and 10) prepare interim data reports for ongoing clinical studies.